Cytoprotection with amifostine in radiotherapy or combined radio-chemotherapy of head and neck cancer

Background: A considerable amount of experimental and clinical data prove t he cytoprotective effect of amifostine on normal tissue exposed to differen t types of antineoplastic treatments. The present study examines its influe nce on the short-term toxicity of either radiotherapy alone or combined rad io-chemotherapy in patients with advanced head and neck cancer. Patients and Methods: Twenty-three patients with advanced head and neck can cer, mainly Stage III and IV, were treated with preoperative radiation (n = 1), pre- as well as postoperative radiotherapy (n = 5), postoperative radi ation (n = 9) or combined postoperative radio-chemotherapy (n = 6). Before each radiation application a total dose of 500 mg amifostine was administer ed intravenously over 15 minutes. The documentation of this unselected pati ent group was compared retrospectively to a historical control group compri sing 17 patients. Results: In 15 patients (65%) of the amifostine group, therapy induced side effects such as mucositis and dermatitis of WHO Grade less than or equal t o 2 were detected, requiring interruptions of the radiotherapy (mean: 6.5, maximum 17 days). No mucose or dermatologic toxicity of WHO Grade 3 or 4 wa s observed in this group. Significantly more acute toxicity was detected in the historical control group. Stomatitis or epitheliolysis of WHO Grade 3 occurred in 7 patients (41%). The side effects induced by the antineoplasti c therapy caused an interruption of treatment in 15 patients (88%) (mean: 1 6, maximum 40 days; p = 0.0016). Conclusion: The application of amifostine before each radiation treatment s eems to result in a distinct reduction of short-term toxicity of radiothera py or combined radio-chemotherapy in patients with head and neck cancer, al lowing for a better adherence to the planned radiation time schedule.